Regulatory Affairs Coordinator
hace 2 semanas
**Summary**:
¿Te apasiona garantizar que los medicamentos lleguen a quienes más los necesitan cumpliendo con los más altos estándares regulatorios? En Novartis, buscamos un/a Regulatory Affairs Coordinator que impulse estrategias regulatorias clave, asegurando el cumplimiento normativo y la excelencia operativa. Este rol es esencial para mantener la integridad de nuestros productos en el mercado colombiano, colaborando con equipos multifuncionales y promoviendo una cultura de cumplimiento. Si buscas un entorno dinámico, con propósito y oportunidades de crecimiento, este es tu lugar.
**About the Role**:
**Responsabilidades Clave**:
- Ejecutar estrategias regulatorias para el registro y mantenimiento de productos farmacéuticos en Colombia.
- Asegurar el cumplimiento normativo en documentación técnica, materiales promocionales y actualizaciones de seguridad.
- Gestionar un sistema de documentación controlado conforme a los requisitos regulatorios locales e internacionales.
- Coordinar auditorías e inspecciones regulatorias, brindando soporte técnico y documental.
- Liderar la cultura de cumplimiento en el área regulatoria, alineada con las políticas de Novartis.
- Colaborar con equipos multifuncionales y stakeholders para garantizar procesos regulatorios eficientes.
- Interpretar y aplicar estándares regulatorios globales y locales en todos los procesos del área.
**Requisitos Esenciales**
- Título profesional en Química Farmacéutica o carreras afines.
- 3 años de experiência en Asuntos Regulatorios de medicamentos de fórmula médica en Colombia (excluyendo prácticas).
- Conocimiento profundo de la regulación sanitaria vigente en Colombia y experiência en procesos regulatorios locales e internacionales y buenas prácticas (GMP, GLP, GDP).
- Experiência en gestión de documentación técnica y cumplimiento normativo.
- Habilidad para planificar y ejecutar proyectos regulatorios en entornos multifuncionales.
- Nível de inglés que permita la comprensión y elaboración de documentación técnica.
- Experiência previa en entornos multinacionales y capacidad para desenvolverse con autonomía y criterio profesional.
**Skills**
- Habilidad analítica y atención al detalle.
- Conocimiento de normativas regulatorias y buenas prácticas (GMP, GLP, GDP).
- Gestión de documentación y cumplimiento normativo.
- Planificación y ejecución de proyectos.
- Capacidad de análisis de datos y elaboración de reportes ejecutivos.
- Comunicación efectiva y liderazgo en actividades de oversight.
- Colaboración con equipos internos y externos.
**Language**
- Inglés.
Division
Development
Business Unit
Innovative Medicines
Location
Colombia
Site
Bogota (Pharmaceuticals / GDD / NTO / CTS)
Company / Legal Entity
CO01 (FCRS = CO001) Novartis de Colombia S.A
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regular
Shift Work
No
-
Regulatory Affairs Coordinator
hace 2 semanas
Bogotá, Cundinamarca, Colombia Convatec A tiempo completo**What will you do?** - Collaborate and influence decisions in a highly matrixed organization, as well as in cross-functional team settings. - Provides direction regarding the quality requirements of Convatec 's new and marketed products, as well as helping support the implementation of long term companywide quality strategies and operating...
-
Regulatory affairs Trainee
hace 2 semanas
Bogotá, Colombia Eli Lilly and Company A tiempo completoRegulatory affairs Trainee page is loaded## Regulatory affairs Traineelocations: Colombia, Bogotatime type: Full timeposted on: Posted Todaytime left to apply: End Date: January 30, 2026 (19 days left to apply)job requisition id: R-99077At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader...
-
Regulatory affairs Trainee
hace 2 semanas
Bogotá, Colombia Eli Lilly and Company A tiempo completoJoin to apply for the Regulatory affairs Trainee role at Eli Lilly and Company At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life‑changing medicines to those who need them, improve...
-
Regulatory Affairs Coordinator
hace 6 días
Bogotá, Colombia Reckitt A tiempo completoIn Research and Development, we're full of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals - all working to create a cleaner, healthier world. With nine Centres of Excellence, we continually seek out new opportunities by using science, our entrepreneurial flare and our fearless innovation to develop...
-
Regulatory Affairs Specialist
hace 2 semanas
Bogotá, Colombia Solventum A tiempo completo**Regulatory Affairs Specialist, Colombia (Solventum)** **3M Health Care is now Solventum** At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material...
-
Regulatory affairs Trainee
hace 2 semanas
Bogotá, Colombia Eli Lilly and Company A tiempo completoAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
-
Regulatory Affairs Manager
hace 2 semanas
Bogotá, Colombia Johnson & Johnson A tiempo completoDE&I Statement For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve...
-
Regulatory Affairs Specialist
hace 1 semana
Bogotá, Colombia Zimmer Biomet A tiempo completoAt Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds. As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life...
-
Senior LATAM Regulatory Affairs Expert
hace 2 semanas
Bogotá, Colombia PowerToFly A tiempo completoA leading medical technologies company in Bogotá is seeking a Regulatory Affairs professional. The role involves developing and applying knowledge of Regulatory Affairs frameworks and supporting both local and global activities. Candidates should have at least 4 years of experience and a BSc in a relevant field. Fluency in English and proficiency in IT...
-
Regulatory Affairs Trainee: Pharma Compliance
hace 2 semanas
Bogotá, Colombia Eli Lilly and Company A tiempo completoA global healthcare leader is seeking a Regulatory affairs Trainee to oversee operational aspects of regulatory affairs in Bogotá, Colombia. The role includes maintaining licenses, handling new registrations, and ensuring compliance. The candidate will engage with external regulatory personnel to achieve objectives. This is a full-time internship position...